A Prospective, randomized , placebo, controlled trial ( double blinded) to assess the potential role of vitamin D treatment in breast cancer patients
Withdrawn
- Conditions
- breast cancer/ breast carcinoma10006291
- Registration Number
- NL-OMON34378
- Lead Sponsor
- Medisch Spectrum Twente
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 110
Inclusion Criteria
primary operable invasive breast cancer
Exclusion Criteria
Previously clinically detected nefrolithiasis (on diagnostic imaging techniques).
Previously clinically detected cholelithiasis (on diagnostic imaging techniques).
History of sarcoidosis.
History of recurrent urolithiasis.
Already taking Vitamin D (colecalciferol) supplement >400 IU/day.
Calcium-lowering therapy within 2 weeks before study entry.
Previously documented impaired renal function.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1. To study the influence of vitamin D on immunohistochemical marker Ki 67<br /><br>(proliferation marker) in breast cancer. This marker will be defined in the<br /><br>biopsy specimen and in the tumour resection specimen. The mean difference<br /><br>between these two marker values will be examined between the intervention and<br /><br>the control group.</p><br>
- Secondary Outcome Measures
Name Time Method <p>1. To study the influence of vitamin D on immunohistochemical markers in biopsy<br /><br>specimen and tumour resection specimen in breast cancer. These markers will be<br /><br>defined in the biopsy specimen and in the tumour resection specimen.<br /><br>o Immunohistochemical markers to be studied are<br /><br>* Caspase 3 (apoptosis marker)<br /><br>* Vitamin D receptors (responsiveness marker)<br /><br>* HER 2Neu-, estrogen- and progesterone-receptor status (tumormarkers)<br /><br>2. To study changes in serum calcium and vitamin D levels between day 1 and day<br /><br>of surgery<br /><br>3. Correlation of initial (=before treatment with vitamin D) serum vitamin D<br /><br>levels with clinicopathological parameters of breast cancer (tumour size, nodal<br /><br>status, grade, estrogen and progesterone receptor status, HER2 status).<br /><br>4. Reporting any eventual adverse effects.</p><br>